Evaluation and EUA validation of a production ready portable, Point-of-Need Platform for detection of COVID-19 direct from nasal swabs in 30 minutes.

BG Research有一种简化的方法用于检测患者的病毒感染，即QuRapID-XF技术。它是为应对埃博拉疫情而开发的，可以直接从患者样本中进行便携式检测。这消除了对实验室或专家用户的需求-重要的是，它被设计用于非洲农村资源贫乏的环境。该项目将产生一种直接从鼻拭子检测COVID-19感染的方法，可以在任何地方使用，例如在入境口岸或通过第一响应者。点检测（APT）对于英国有效应对COVID-19至关重要。这种方法是一种高度敏感的便携式平台，可确保感染者和那些没有症状但感染（早期）的患者能够被迅速识别和隔离。.便携式分子检测系统可以在任何地方使用，并在患者等待的30分钟内给出结果。这种COVID-19检测将直接从鼻拭子中进行，但该技术直接从唾液，血液，尿液或其他原始样本中进行检测。QuRapID-XF检测很简单，因此可以由非专业人员（如士兵和护士）进行，并且可以进行大量的等待测试。基于分子诊断的抗原检测比侧流检测、免疫学检测灵敏许多倍，并且可用于区分引起例如呼吸道症状的不同病毒性疾病，如流感。该项目将看到该平台技术的规模化发布。PHE将能够在平台上部署自己的检测，以快速应对未来的血源性和呼吸道病毒爆发。疾病QuRapID-XF还可以为较贫穷的发展中国家带来低成本的检测。由于该方法不需要核酸提取，并且使用我们自己的试剂和仪器，因此不会出现与检测相关的供应链问题，因此可以快速提供大量检测，以应对未来的任何疫情。该检测方法将在多个地点和国家进行性能评估，确保测试将是高度敏感的。这项技术使英国能够应对生物安全威胁，以及全球范围内人类或兽医病毒性疾病的爆发，减少疾病造成的死亡率和经济损失。

BG Research have a simplified method for testing patients for infections caused by viruses, the QuRapID-XF technology. Developed in response to the Ebola outbreak, it enables portable testing directly from patient samples. This removes the need for a lab or expert users -- important as it was designed to be used in resource poor environments in rural Africa.This project will generate a direct from nasal swab test for COVID-19 infections that could be used anywhere, for example at ports of entry or via first responder. At-Point-Testing (APT) will be vital to effectively deal with COVID-19 in the UK. This approach is a highly sensitive, portable platform that ensures infected and those with no symptoms but infected(early stage) patients can be rapidly identified and isolated . . The portable molecular testing system can be used anywhere and gives results within 30 minutes while the patient waits . Hence facilitating immediate isolation and contact tracing.This COVID-19 test will work directly from nasal swabs, but the technology detects directly from saliva, blood, urine or other crude samples. QuRapID-XF assays are simple, so can be performed by non-expert personnel such as soldiers and nurses and large numbers of while-you-wait tests could be performed. Antigen tests based on molecular diagnostics are many times more sensitive than lateral flow tests, immunological tests, and can be used to differentiate between different viral diseases causing e.g. respiratory symptoms, such as the flu.This project will see the scaled release of this platform technology.PHE will be able to deploy their own assays onto the platform to rapidly respond to future outbreaks of blood borne and respiratory viral diseases. QuRapID-XF can also bring low cost testing to poorer developing nations.As the approach doesn't require nucleic acid extraction and uses our own reagent and instrument, there will be none of the supply chain issues seen relating to testing and so it will be possible to deliver large numbers of tests rapidly in response to any future outbreaks.The assay will go through a performance evaluation at multiple sites and countries, ensuring that the test will be highly sensitive. This technology allows the UK to respond to biosecurity threats, and outbreaks of human or veterinary viral diseases globally, reducing mortality and economic losses caused by disease.